It was noted above, the Medicare contractor for the state of Pennsylvania continued to provide coverage for chemoresponse assays and that there is an experienced laboratory in Pennsylvania (Precision Therapeutics) which both provided the assays and accepted Medicare reimbursement as payment in full.
The California laboratories that continued to provide chemoresponse assays with functional profiling (without Medicare reimbursement, possibly requiring patient payment for services) included Rational Therapeutics, Anticancer, Inc., and Weisenthal Cancer Group.
It looks like Novitas Solutions, Inc. (formerly Highmark Medicare Services) has arbitrarily made the decision, like Palmetto, GBA did in California, to discontinue Medicare payment for chemoresponse assays done by Precision Therapeutics in Pennsylvania.
The rationale for the non-coverage decision is totally bogus. It's a shame. The biggest thing is that the "expert reviews" upon which they rely on made no attempt whatsoever to determine the "accuracy" of the tests being evaluated.
They all used the phony, made-up criterion of test "efficacy" -- demanding rigorous proof that the use of the tests improves outcome -- which is a standard not achieved by any of the large number of laboratory tests currently used to assist in treatment/drug selection in oncology -- or for that matter, in medicine in general.
The only criteria ever used to evaluate laboratory or radiographic tests has been the accuracy of the tests. And this criterion was totally ignored in the reviews. They just made up their minds in advance that they didn't want to pay for the tests.
ASCO made up its mind in advance that it didn't want to have anything to do with the tests (for a lot or reasons, including the certainty that it would siphon patients away from their clinical trials). So they erected an impossibly high bar.
One of the major reasons academic cancer institutions don't like in vitro chemosensitivity test is that it may be in direct competition with their randomized controlled clinical trial paradigm - a fiercely defended relic of their ignorance.
Cell culture assay measure the "efficacy" of anti-cancer drugs. The randomized clinical trial measures the "efficacy" of anti-cancer drugs. And the new molecular testing rates the "efficacy" of population research vs rating the "efficacy" of drugs "actually" tested against an individual's cancer cells.
The oncologist’s trade group, American Society of Clinical Oncologists (ASCO) says oncologists should make chemotherapy treatment recommendations on the basis of published reports of clinical trials and a patient’s health status and treatment preferences. All the rigorous clinical trials identified are the best treatments for the “average” patient (do cancer cells like Coke or Pepsi). But cancer is far more heterogeneous in response to various individual drugs than are bacterial infections. The tumors of different patients have different responses to chemotherapy.
The ASCO tech assessments say that chemotherapy sensitivity and resistance assays (CSRAs) should not be used outside the confines of a clinical trial setting. The same people who maintain that assay-directed therapy should not be used until proven in prospective randomized clinical trials, are the same people whose entire careers are utterly dependent upon mega-trials 100% funded by pharmaceutical companies (that, plus fees from speeches they give for these companies), are the same people who control the clinical trials system, the grant review study sections, and the journal editorial boards.
No wonder ASCO doesn’t recommend the use of CSRAs (no matter how good they are) to select chemotherapeutic agents for individual patients outside of the clinical trial setting. Besides the authors of these tech assessments trying to invent a brand new criterion for validating a laboratory test, they’d like to have these tests in clinical trials. Tens of thousands of scientists pushing a goal of finding the tiniest improvements in treatment rather than genuine breakthroughs that fosters redundant problems and rewards academic achievement and publication above all else.
Why is ASCO (and others) protecting the status of treatments which are only marginally and minimally and inconsistently effective? This prevents serendipitous and fortuitous discovery. Truly effective treatment don’t need prospective randomized trials. Even ASCO points out, because the number of available chemotherapeutic agents has increased enormously over the past few years, the emphasis on the rationale for these assays have never been stronger. As the number of possible treatment options supported by completed randomized clinical trials increases, the scientific literature becomes increasingly vague for guiding physicians.
With all these uncertainties, would it be wrong to make a clinical decision based on CSRAs? Should it be denied to patients who walk in the door asking for it? Patients who want this testing, after a thorough discussion about the peer-reviewed studies and experience that supports it, should not be hindered by restrictive ASCO policy. I never heard that ASCO had been knighted a regulatory agency.
Until the controlled, randomized trialist approach has delivered curative results with a high success rate, the choice of physicians and patients to integrate promising insights and methods like chemoresponse assays, remains an essential component of this kind of treatment technology.
Michael Castro, M.D., stated on the Rational Therapeutics blog, "In 1992, the Church publicly forgave Galileo for his “crime” of the heliocentric theory…a lesson in the slow pace of circumspection by authoritative bodies… seems we haven’t yet overcome an analogous religious intolerance in medical oncology and I’m not holding out for an apology from ASCO any time soon, but eventually it may come… Certainly, the insistence on population medicine at a time when the technology for individualized medicine has arrived borders on religious intolerance, not the scientifically curious patient advocacy patients want and naively expect… I’m afraid this intolerance is buttressed by the economic incentives of giving drugs to as many individuals as possible – a double problem…."
https://www.novitas-solutions.com/po...ab/l32571.html